In short: On January 31, 2025, FDA issued a Form 483 with 8 observations to B. Braun US Pharmaceutical Manufacturing LLC in Daytona Beach, Florida (FEI 3014200891) after an inspection that ran Jan 22 – Jan 31, 2025. The investigators were Evan Tong and Yaharn Su. Most observations concern production and facilities & equipment.
At a glance
3 of 4 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups…
- 04
Your examination and testing of samples did not assure that the drug product and in-process…
This inspection in context
Evan Tong
6 documents · 2023–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmB. Braun US Pharmaceutical Manufacturing LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.103
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at B. Braun US Pharmaceutical Manufacturing LLC?
FDA listed 8 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected B. Braun US Pharmaceutical Manufacturing LLC?
Evan Tong and Yaharn Su are named on this Form 483, for the inspection of Jan 22 – Jan 31, 2025. Each investigator has a profile showing what they cite most.
When was B. Braun US Pharmaceutical Manufacturing LLC inspected by FDA?
The inspection ran Jan 22 – Jan 31, 2025, and the Form 483 is dated January 31, 2025.
How do I get the full Form 483 for B. Braun US Pharmaceutical Manufacturing LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.